Multicenter Investigation Research Articles

Neighborhood deprivation is a risk factor for severe child physical abuse: A multicenter cohort investigation.

Our purpose was to investigate whether neighborhood deprivation is associated with outcomes in a multicenter population of children with suspected or confirmed child physical abuse. We hypothesized that community level social determinants of health are associated with worse outcomes following child physical abuse. This multicenter retrospective review included children (18 years or younger) admitted with suspected or confirmed physical abuse at six pediatric trauma centers. A national Area Deprivation Index (ADI) score was assigned to each patient based on home address. Area Deprivation Index was divided into quartiles using the distribution of our dataset. Exclusion of a caregiver at discharge was used as a proxy for confirmed physical abuse. Descriptive statistics and stepwise logistic regression were used to identify covariates. Multiple logistic regression was used to test for associations between ADI and caregiver exclusion. Of 1,105 included patients, 512 had confirmed abuse. These patients were younger (median [interquartile range], 0.50 [1.50] vs. 0.83 [1.67]; p = 0.002), more likely to be Black or African American (28.3% vs. 19.5%, p < 0.001), and had higher ADI scores (81.0 [35.0] vs. 66.0 [60.0], p < 0.001). A dose-dependent relationship between ADI and caregiver exclusion was identified. Compared with those from the least vulnerable neighborhoods (ADI first quartile), patients from the most vulnerable neighborhoods (ADI fourth quartile) had 2.65 (95% confidence interval, 1.73-4.08; p < 0.001) times higher odds of confirmed abuse. Despite no differences in Injury Severity Scores (8.0 [6.0] vs. 9.0 [10.0], p = 0.163), they also had longer lengths of hospital stay (1.0 [2.0] vs. 3.0 [2.8], p = 0.002) and higher mortality (1.5% vs. 5.0%, p = 0.028). This large multicenter experience demonstrates a dose-dependent relationship between socioeconomic disadvantage and child physical abuse. We further demonstrate that disadvantage is associated with worse outcomes, including increased mortality, in child physical abuse. These findings provide objective data and lead to suggestions for interdisciplinary and multiscale approaches to primary prevention of child physical abuse. Prognostic and Epidemiological; Level III.

P-1252. Individualizing Antibiotic Therapy: Pharmacokinetic Approach to Evaluate and Optimize dosing of Meropenem in Critically Ill Sepsis Patients

Abstract Background The optimization of antibiotic dosing poses a considerable challenge, particularly in cases of Sepsis with acute renal impairment requiring continuous renal replacement therapy (CRRT). This study centers on the widely prescribed broad-spectrum beta-lactams, specifically meropenem, recognizing its extensive use in severe and complex clinical scenarios. The primary objectives of this study is to formulate new guidelines facilitating dose individualization, thus enhancing therapeutic outcomes for this critical population. Meropenem dosing recommendations for sepsis shock patients with acute renal impairment Methods Three studies were conducted based on specific hypotheses. The initial study involved a comprehensive systematic literature review aimed at critically evaluating the existing evidence regarding the dosing regimens of meropenem. Subsequently, Studies 2 and 3 were undertaken as observational, prospective, open-labeled, multicenter pharmacokinetic investigations within the Intensive Care Unit of a prominent tertiary care hospital in Coimbatore, India. The study cohort comprised thirty patients administered with meropenem experiencing septic shock with acute renal impairment requiring continuous renal replacement therapy. Population Pharmacokinetic models were meticulously developed, validated, and subjected to Monte Carlo simulations for comprehensive analysis. Results A comprehensive literature review exposed the limitations of current dosing recommendations, pointing to varied sickness severities, renal function levels, admission diagnostics, CRRT settings, and disparate pharmacokinetic (PK) methodologies. For meropenem, a crucial relationship between 24-hour urine output and total clearance emerged. Oligoanuric patients (&amp;lt; 100mL/24h) displayed a 30% decrease in total clearance compared to those with preserved diuresis ( &amp;gt;500mL/24h). Monte Carlo simulations supported tailored dosing recommendations, addressing bacterial susceptibility and patient diuresis status. Conclusion For optimal antibiotic dosing, our findings highlight the importance of considering clinical and demographic factors, including 24-hour urine output and patient weight. These insights can be implemented at the bedside to help navigate the complexities of antibiotic optimization within the Intensive Care Unit. Disclosures All Authors: No reported disclosures

The role of ferroptosis and oxidative stress in cognitive deficits among chronic schizophrenia patients: a multicenter investigation

Oxidative stress (OS) is crucial in schizophrenia (SCZ) pathology. Ferroptosis, a recently discovered cell death pathway linked to OS, might contribute to the development of SCZ. This study investigated the association between ferroptosis markers and cognitive impairments in chronic SCZ patients. A retrospective analysis was conducted on 204 chronic SCZ patients with cognitive deficits and 216 healthy controls (HC) matched for relevant characteristics. Plasma levels of ferroptosis and OS markers, including iron, ferritin (FE), transferrin (TF), glutathione peroxidase 4 (GPX4), long-chain acyl-CoA synthetase 4 (ACSL4), glutathione (GSH), sirtuin 1 (SIRT1), nuclear factor erythroid 2-related factor 2 (Nrf2), malondialdehyde (MDA), and superoxide dismutase (SOD) were measured. Standardized assessments like the positive and negative syndrome scale (PANSS), and Montreal Cognitive Assessment (MoCA) were used to evaluate psychiatric symptoms, and cognitive function. SCZ patients showed significant differences in markers compared to the HC group (P < 0.01). Multiple linear regression analysis revealed that decreased GSH and iron levels, along with elevated SOD levels, were significantly associated with the overall severity of psychiatric symptoms. Additionally, reduced GPX4 levels and increased ACSL4 and FE levels were significantly linked to negative symptoms and cognitive impairments. Notably, GPX4 emerged as a key predictor for cognitive function in abstraction and language domains. Our study revealed alterations in the altered plasma levels of GPX4, GSH, iron, ACSL4, FE, and SOD in chronic SCZ patients, which might indicate a close association between biomarkers of ferroptosis and OS and the psychiatric symptoms and cognitive deficits observed in these individuals.

Non-Target Hemangioma Size Reduction After Bleomycin-Lipiodol Embolization of Primary Hepatic Hemangioma.

To evaluate changes in non-target hepatic hemangiomas, which are neither subjected to embolization nor targeted for treatment, following selective bleomycin-lipiodol transarterial chemoembolization (TACE) of a giant hepatic hemangioma. This single-center retrospective study included 24 patients with non-target hepatic hemangiomas distinct from primary giant hemangiomas treated with selective bleomycin-lipiodol TACE between 2009 and 2022. The size and volume of the lesions were assessed using computed tomography scans obtained before treatment, and at 6, 12 and 24 months. A significant reduction in the size of non-target lesions (n = 34) was observed during follow-up (P < 0.05). 18 of 34 lesions (53%) showed a reduction in volume of 50% or greater. Overall clinical success rate for the primary lesion, defined as a significant size reduction and symptom improvement, was 96%. Logistic regression analysis showed no statistically significant association between demographic or primary lesion variables and changes in non-target lesions (P = 0.901). Spearman's correlation analysis revealed no significant relationship between changes in primary and non-target lesions (P > 0.05). Bleomycin-lipiodol TACE of a giant hepatic hemangioma significantly reduced the size of non-target hemangiomas. This may be related to systemic absorption of the chemotherapeutic agent, lymphatic dissemination, or an abscopal effect, though the exact mechanism remains unclear. Further validation through multicenter studies, longer follow-up, and prospective investigations into immune mechanisms is required.

Characterizing Nonalcoholic Fatty Liver Disease (NAFLD) in Lean Individuals at a Tertiary Care Hospital: A Cross-sectional Study.

Fat accumulation in the liver is affecting 38% of the global population. It can also occur in normal-weight individuals, termed lean non-alcoholic fatty liver disease (NAFLD). This study examines Asian and Western body mass index (BMI) criteria, as well as metabolic dysfunction-associated fatty liver disease (MAFLD) and metabolic dysfunction-associated steatotic liver disease (MASLD) diagnostic guidelines, in lean fatty liver cases within a healthcare setting. This study was cross-sectional included 111 lean patients diagnosed with NAFLD using either ultrasound or VCTE from January 2023 to March 2024. Anthropometric, laboratory and non-invasive liver fibrosis evaluation parameters were used. The study assessed clinical characteristics and metabolic risk factors of patients with BMI ≤ 23 kg/m2 and BMI between 23 and ≤ 25 kg/m2 using MASLD and MAFLD diagnostic criteria. The cohort included NAFLD patients with a mean age of 43.3 years (±13.2 years). Of the participants, 33% were diagnosed through ultrasonography, whereas 67% diagnosis were made via Fibro scan. Majority were male 92 (83%), while females were 19 (17%) of the entire group. The lean NAFLD criteria for Asia and the West were satisfied by 43 (39%) persons with a BMI ≤ 23 kg/m2 and 68 (61%) individuals with a BMI between 23 and ≤ 25 kg/m2, respectively. The average body mass index (BMI) was 23.0 ± 1.5 kg/m2. Diabetes was observed in 16%, hypertension 11%, and ischemic heart disease in 2%. Out of the total individuals, 92 satisfied the MASLD-MAFLD criteria, whereas 18 did not qualify the MAFLD criteria for diagnosis and were classed as MASLD-Alone. Elevated triglycerides, insulin resistance (HOMA-IR ≥ 2), and three or more cardiometabolic risk factors (CMRF) were significant in the MASLD-MAFLD group compared to the MASLD-Alone group (p < 0.05). Comparing BMI criteria, no significant differences were found in terms of fibrosis between the Western and Asian lean NAFLD BMI criteria's (p = 0.243). Lean NAFLD is a major global health concern. Applying non-Asian BMI criteria (BMI ≤ 25 kg/m2) for lean Asians improves early detection and intervention for at-risk individuals. Accurate use of MAFLD and MASLD criteria is essential to prevent confusion in diagnosing lean NAFLD. Further multicenter investigations with larger sample numbers are required to corroborate these results in our community. Nazir S, Abbas Z, Gazder DP, et al. Characterizing Nonalcoholic Fatty Liver Disease (NAFLD) in Lean Individuals at a Tertiary Care Hospital: A Cross-sectional Study. Euroasian J Hepato-Gastroenterol 2024;14(2):198-204.

Clinicopathological features and treatment outcomes of urothelial carcinoma variant histologies and non-urothelial bladder cancers.

Most bladder cancers are pure urothelial carcinomas, but a small portion, approximately 5-10%, have variant histology or are non-urothelial in nature. This research sought to examine the features of and treatment strategies for different types of urothelial carcinoma with variant histologies and non-urothelial bladder cancer. The study cohort comprised individuals with non-urothelial and variant urothelial bladder cancers treated at two medical centres in Ankara, Turkey, between 2005 and 2024. A total of 104 individuals were reviewed, with 88 having urothelial cancer with variant histology and 16 having non-urothelial cancer. Non-urothelial cancers included neuroendocrine, undifferentiated, adenocarcinoma, squamous, sarcoma, and carcinosarcoma, with a median overall survival (OS) of 8months. The most frequent urothelial carcinoma variants were squamous (43 cases), plasmacytoid (9 cases), and sarcomatoid (6 cases). Individuals with operable variants of urothelial malignancies had a median disease-free survival (DFS) of 16.5months, while individuals with inoperable/metastatic variants experienced a median progression-free survival (PFS) of 8.9months. The median OS in the operable cohort was 18.5months, compared to 10.8months in the inoperable/metastatic group. The present study reveals that variant urothelial and non-urothelial bladder cancers are aggressive in nature and have poor prognosis. Given the significant heterogeneity observed in OS, DFS, and PFS among these rare and diverse tumor subtypes, large-scale multicenter investigations are required to establish a consensus on patient handling and treatment.

Self-Harm as a Contributor to the Opioid Epidemic: Data From the Toxicology Investigators Consortium Registry.

Although considerable focus has been placed on understanding the causes of opioid drug overdoses, the intentions for such overdoses are not well characterized. We investigated the motivations behind nonfatal opioid exposures resulting in serious adverse health outcomes. We analyzed prospectively collected data on nonfatal opioid overdoses in the multicenter Toxicology Investigators Consortium (ToxIC) Core Registry between 2014 and 2021. Included patients were age ≥11 years with serious toxicity after use of pharmaceutical and/or nonpharmaceutical opioids for whom the reasons for opioid exposure were determined. Pharmaceutical opioids were defined as United States Food and Drug Administration-approved medications. All other opioids were classified as nonpharmaceuticals. The 5250 cases meeting the criteria were 56.6% male with a median age of 36 years (IQR, 26-50). There were 2960 (56.4%) opioid misuse cases and 1456 (27.7%) self-harm attempts. Within the self-harm group, 1242 (85.3%) were suicidal, and 1187 (95.6%) of these used pharmaceutical opioids in their suicide attempt. Only 94 (4.2%) patients using nonpharmaceutical opioids did so in a suicide attempt. Pharmaceutical opioid suicide attempts as a percent of all registry cases peaked between 2015 and 2017 and fell dramatically thereafter (P = 0.005). For comparison, benzodiazepine overdoses similarly decreased (P = 0.003), whereas non-opioid analgesic or antidepressant overdoses increased. A majority of serious opioid overdoses were sequelae of opioid misuse, but over a quarter were intentional self-harm attempts, primarily involving pharmaceutical opioids. Decreased prescribing of opioids and benzodiazepines after 2016-2017 may have resulted in decreased pharmaceutical opioid and benzodiazepine misuse and self-harm attempts. Similar trends were not seen for nonpharmaceutical opioids.

Effectiveness and safety of VISULAS® green selective laser trabeculoplasty: 12 months retrospective data

To report the safety and effectiveness of selective laser trabeculoplasty (SLT) using the SLT mode of the VISULAS® green laser in patients with primary open-angle glaucoma (POAG). Twelve months results are presented. Retrospective extension in 4 German centers of an initially prospective interventional multicenter 3-month clinical investigation using the VISULAS® green SLT (Carl Zeiss Meditec AG, Jena, Germany) in patients with POAG who either needed treatment escalation or commenced treatment and had an IOP ≥ 17mmHg at baseline, with no previous glaucoma or other ocular surgery. Non-overlapping laser spots (100) were applied in a single session to 360° of the trabecular meshwork (TM). Glaucoma medications were not changed up to the 3-month visit. From 3 to 12 months, patients were managed according to routine standard of care. Outcome measures included IOP reduction, further glaucoma interventions, and adverse events from baseline to month 12. 25 eyes of 25 POAG patients (mean age 65.8 ± 8.5; modified intention to treat – mITT –group) were included in the extension study. Six eyes (24%) underwent additional glaucoma treatment or changed glaucoma therapy; the remaining 19 eyes (76%) had stable glaucoma therapy (SGT group) with no further glaucoma intervention or change in glaucoma medications (mean number of preoperative glaucoma medications: 2.3 ± 1.34). In the SGT group, mean baseline IOP (mmHg) was reduced from 20.0 ± 2.11 at baseline to 17.4 ± 3.25 and 16.2 ± 1.83 at 6 to 12 months, respectively (p < 0.0001): 52.6% had ≥ 20% IOP reduction at 12 months. Potential device- or procedure-related adverse events were mild to moderate and resolved without sequelae. SLT performed with the VISULAS® green laser reduced IOP in eyes with POAG up to 12 months with no relevant safety issues. The results are comparable to other reported SLT studies.

Anemia, iron metabolism, and anemia medication habits in patients undergoing maintenance hemodialysis and peritoneal dialysis are different: a multicenter investigation.

This study aimed to investigate anemia, iron metabolism status, and treatment in patients undergoing maintenance hemodialysis (HD) and peritoneal dialysis (PD). Patients aged ≥ 18years undergoing HD and PD were surveyed using a case report form to collect information. Data were collected from 1071 patients undergoing HD and 630 undergoing PD at eight centers. Anemia was observed in 96.2% of the patients (96.7% for HD vs. 95.2% for PD, P = 0.121). Of these, 38.3% had hemoglobin (Hb) levels between 110 and 130g/L (41.2% for HD vs. 33.3% for PD, P < 0.001), 22.8% had absolute iron deficiency (ID) (31.2% for HD vs. 8.4% for PD, P < 0.001), and 5.8% had functional ID (4.7% for HD vs. 7.6% for PD, P = 0.012). Among patients with Hb < 110g/L, 13.0% received no treatment with erythropoiesis-stimulating agents (ESAs, all recombinant human erythropoietin) or hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHI, all roxadustat) (12.6% for HD vs. 13.6% for PD, P = 0.667), while 64.6% had no iron treatment (69.4% for HD vs. 57.4% for PD, P < 0.001). Logistic regression was used to explore the relationship between dialysis mode and hemoglobin target achievement, suggesting that the attainment of hemoglobin targets may be associated with the use of ESAs or HIF-PHI. Anemia, iron metabolism, and medication habits have distinct characteristics in patients undergoing HD and PD. Iron deficiency is prevalent, and achieving hemoglobin targets is suboptimal, possibly influenced by the administration of ESAs or HIF-PHI. Therefore, timely adjustments of medication habits are necessary to prevent anemia exacerbation.

Predictive model of the surgical difficulty of robot-assisted total mesorectal excision for rectal cancer: a multicenter, retrospective study

Rectal cancer robotic surgery is becoming more and more common, but evidence for predicting surgical difficulty is scarce. Our goal was to look at the elements that influence the complexity of robot-assisted total mesorectal excision (R-TME) in the medical care of middle and low rectal cancer as well as to establish and validate a predictive model on the basis of these factors. Within this multicenter retrospective investigation, 166 consecutive patients receiving R-TME between January 2021 and December 2022 with middle and low rectal cancer were included and categorized according to the median operation time. A nomogram was created to forecast the procedure’s complexity after variables that could affect its difficulty were found using logistic regression analysis. Using R software, a total of 166 patients were randomly split into two groups: a test group (48 patients) and a training group (118 patients) at a ratio of 7 to 3. The median operation time of all patients was 207.5 min; patients whose operation time was ≥ 207.5 min were allocated to the difficult surgery group (83 patients), and patients whose operation time was < 207.5 min were allocated to the nondifficult surgery group. Multivariate analysis revealed that body mass index (BMI), the gap between the tumor and the anal verge and the posterior rectal mesenteric thickness were independent predictors of surgical duration. A clinical predictive model was created and assessed employing the above independent predictors. The results of the receiver operating characteristic (ROC) analysis revealed the adequate discriminative ability of the predictive model. Our study revealed that it is feasible to predict surgical difficulty by obtaining clinical and magnetic resonance parameters for imaging (the gap between the anal verge and the tumour, and posterior mesorectal thickness), and these predictions could be useful in making clinical decisions.

Cost effective clinical methods to evaluate the efficacy of gait training devices: A systematic review of randomized controlled trials

Abstract Aim: This systematic review was aimed at identifying cost-effective outcome assessment metrics to perform clinical trials for assessing the efficacy of novel, low-cost gait training devices. Materials and methods: The search was conducted by the investigators through electronic databases, namely SCOPUS (91), Web of Science (93), PubMed (141) and Cochrane Library (164), from origination to 31st March 2024. The study design was a PRISMA style systematic review of randomized controlled trials (RCTs) of robotic gait training devices (RGTDs) that treated stroke patients. Results: Based on our inclusion and exclusion criteria, 17 randomized controlled trials were studied to identify suitable outcome assessment measures. This involved 705 patients at different stages of stroke, who were treated with different intervention durations, devices, randomization and blinding methods. It was observed from the extensive clinical trials with the RGTDs that it was tested with a variety of assessment methods. Cost-effective outcome assessment measures that require commonly available materials are chosen and discussed in this review. It is identified that the most extensively used measures possess concurrent validity, sufficient inter-rater, intra-rater and test-retest reliability. Conclusion: Clinical trials with a sophisticated setup cannot be afforded by clinics in low-income countries. It is vital to identify assessment methods that require commonly available materials that do not incur huge material costs. The methods discussed in this review can be administered without special training. This can facilitate quantifying and comparing the efficacy of these devices through clinical trials and multi-centric investigations.

Transforming Chronic Pain Care Through Telemedicine: An Italian Perspective.

Chronic pain (CP) is a complex and debilitating condition that significantly impairs quality of life and imposes a high burden on healthcare systems. This study aims to evaluate the impact of telemedicine on chronic pain management in cancer survivors with complex CP. Our multicenter retrospective investigation of cancer survivors with complex CP included 100 patients (median age 65 years, 62% female). Pain, disability, and self-perceived health status were assessed using the Numeric Rating Scale (NRS), Brief Pain Inventory (BPI), Oswestry Disability Index (ODI), and the EuroQolfive-dimension five-level (EQ-5D-5L) questionnaire. The most common diagnoses were neuropathic pain (54%) and complex chronic pain (32%). Significant clinical improvements were observed after six months of telemedicine intervention (all p < 0.001). NRS scores improved by more than four points in 77% of patients, BPI Worst Pain Scores decreased by four points in 52% and by five points in 28% of patients. All patients' disability levels improved from severe (median ODI score of 52) to moderate (median ODI score of 30). Self-perceived health status improved from 40 to 60 on the EQ-5D-5L scale. Telemedicine interventions significantly reduced pain intensity, decreased disability levels, and enhanced quality of life in chronic pain patients. These findings underscore the transformative potential of telemedicine in chronic pain management and support its broader integration into medical practice.

Identification of health trajectories of patients with persistent spinal pain syndrome type 2 using latent class trajectory methods.

Persistent spinal pain syndrome Type 2 (PSPS-T2) is a long-lasting condition that consists of persistent pain following spinal surgery. Although this condition has long-term effects, it is currently studied at a given time point or over a limited period of time, which does not reflect the true impact of pain patients. To bridge this gap, we used latent class trajectory models to extract clusters with different trajectories of patients with PSPS-T2. Data from the PREDIBACK study, an observational, multicentric, and longitudinal investigation carried out prospectively, were used. This study focuses on patients with PSPS-T2, tracking their outcomes at 3-month intervals over a one-year period. Health status was evaluated using a novel multidimensional clinical response index (MCRI). The trajectories of patients' health status were extracted using mixture of mixed effect models. Two hundred (200) PSPS-T2 patients were included. Two clusters were identified, including 'persistent low health' trajectories (63.1%) and 'improving health' trajectories (36.9%). Regarding the factors associated with these trajectories, our results showed that lower age, lower body mass index, lower pain intensity, lower functional disability, lower anxiety and less extended pain surface were associated with improving health status. Clustering methods provide an opportunity to identify two distinct clusters of pain-related health trajectories of PSPS-T2 patients. Persistence of the symptoms was not observed in one third of the PSPS-T2 study patients, who belong to the improving pain-related health cluster, while the other two thirds did not achieve improved health over a 1-year follow-up. Our study findings suggest that the use of trajectory-based methods could improve patient evaluation and pain management as it allows for obtaining a global view of patients during their care pathway compared to conventional methods, which only focus on specific visits. Our study also advocates for multidimensional assessment and management of pain by targeting not only pain intensity but also the psychological distress, functional capacity and pain surface at an early stage of pain onset after spine surgery.

Definitions matter: Multicenter investigation of incidence and outcome of poor graft function after hematopoietic cell transplantation.

Despite advances in allogeneic hematopoietic cell transplantation (HCT), poor graft function (PGF) remains an important complication with substantial morbidity and mortality. The investigation of preventive and therapeutic PGF treatments is hindered by inconsistencies in reported incidence and outcomes across studies, which may be explained by heterogeneity in PGF definition. To assess the impact of definition heterogeneity, we conducted a multicenter study, analyzing over 35.000 longitudinal blood counts from 427 pediatric and 405 adult HCT recipients. We compared the incidence, risk factors, and outcome of PGF, based on the three most common definitions. We identified 97 pediatric and 75 adult HCT recipients fulfilling at least one PGF definition. The 2-year cumulative incidence of PGF varied significantly depending on the definition used, ranging from 6.8% to 20% in children and 4.9% to 18% in adults. Two-year mortality for PGF patients ranged from 33% to 40% in children and 46% to 65% in adults. Notably, PGF patients identified solely by lenient definitions had similar mortality to HCT recipients with good graft function. Risk factors for PGF also varied by definition in both cohorts, and included older recipient age and cord blood transplantation. In conclusion, our study demonstrates that differences in PGF definition significantly impact the reported incidence, risk factors, and outcome. This underscores the need to harmonize PGF definitions across scientific studies, clinical practice, and transplant registries. Future studies, using standardized, quantitative thresholds for PGF, are required to determine optimal treatment strategies for both mild and severe forms of PGF.

Serum Autotaxin Levels Predict Liver-Related Events in Patients With Primary Biliary Cholangitis: A Long-Term Multicenter Observational Study.

A straightforward, reliable, and noninvasive method for predicting the development of liver-related events (LRE) in primary biliary cholangitis (PBC) has not been attained thus far. This study investigated whether serum autotaxin (ATX) could predict LRE in patients with PBC. This retrospective multicenter investigation included 190 biopsy-proven untreated patients with PBC. All subjects were followed for at least 1 year, during which time the prevalence of LRE, including newly developing hepatocellular carcinoma, esophagogastric varices, ascites, and hepatic encephalopathy, was investigated in relation with ATX levels at the time of liver biopsy. During the median follow-up period of 9.7 years, LRE were observed in 22 patients (11.6%). The area under the receiver operating characteristic curve and cutoff value of serum ATX for predicting LRE were 0.80 and 1.086 mg/L, respectively. Patients with serum ATX ≥1.086 had a significantly higher cumulative incidence of LRE compared with patients with ATX < 1.086 (33.3% vs 3.6%, P < 0.00001). Notably, the predictive capability of ATX for LRE in patients with PBC surpassed that of FIB-4, ALBI, APRI, and Mac-2-binding protein glycan isomer. A multivariate Cox proportional hazards model revealed ATX as an independent associated factor for LRE (hazard ratio 6.24, 95% confidence interval 1.87-20.80, P = 0.003) along with Nakanuma stage (hazard ratio 2.75, 95% confidence interval 1.52-4.99, P < 0.001). These results were closely replicated in a serologically diagnosed PBC validation cohort (n = 32). Serum ATX levels may serve as a predictive marker for LRE in patients with PBC.

Clinical performance and cost-effectiveness of a Silicone foam with 3DFit™ technology in chronic wounds compared with standard of care: An open randomised multicentre investigation.

The objective of the study was to show the clinical performance and cost-effectiveness of a Silicone foam dressing with 3DFit™ Technology compared to current standard of care. This was an open-labelled, two-arm, randomised controlled multicentre study conducted from February to December 2023. One hundred and two participants with an exuding, non-infected and chronic ulcer were randomised in a 1:1 fashion and treated with either a Silicone foam with 3DFit™ Technology or standard of care (a filler combined with a secondary dressing), stratified by venous leg ulcers and diabetic foot ulcers. After a 4-week study period, wound size and total costs were evaluated. After 4 weeks of treatment, a comparable percentage in wound area reduction was observed in both treatment arms with mean and 95% confidence interval of 54.3% (37.1%; 71.5%) and 43.0% (26.5%; 59.6%) for the investigational and comparator dressing, respectively. This corresponded to a mean difference of 11.3% ([-10.22; 32.86], p = 0.299). Total mean estimated costs were significantly lower for the investigational dressing (£14.3, 95% confidence interval [£9.6; £19.0]) compared to the two-dressing regime (£21.4 [£16.9; £26.0]), corresponding to a 33% price reduction (p = 0.033) after 4 weeks of treatment. With this RCT, a conforming Silicone foam dressing with 3DFit™ Technology was shown to be clinically comparable and a cost-effective alternative to using a filler and a secondary dressing at a significantly lower cost in both venous leg ulcers and diabetic foot ulcers up to 2 cm in depth.

“Comprehensive Analysis of Factors Influencing Recurrence and Survival in Glioblastoma: Implications for Treatment Strategies”: A Single Center Study

Glioblastoma is a highly aggressive malignancy affecting the brain and central nervous system. It is the most common malignant primary brain tumor, yet its prognosis remains poor. Median survival typically ranges from around 13 months with standard treatment to up to 19.9 months in some recent clinical trials. Despite advances in treatment, the aggressive nature of glioblastoma continues to present significant challenges for improving patient outcomes. This study aimed to analyze various biological, radiological, and molecular factors associated with glioblastoma recurrence and to estimate survival outcomes. A total of 104 glioblastoma patients diagnosed between January 2017 and September 2022 were included. Patient demographics, treatment received, and molecular characteristics were obtained from the Electronic Patient Record (EPR). Tumor molecular characteristics were analyzed using the OnkoSight Advanced CNS NGS panel. Statistical analyses were performed to develop a prognostic model for glioblastoma recurrence and estimate survival rates. Among the patients, 65.4% had no recurrence, with a mean age of 63 years. No gender or BMI differences were observed, but ages &lt;60 years were associated with recurrence. Radiological findings showed no significant differences in tumor size, necrosis, site, or focality. In multivariate analysis, the female gender, obesity, old age (&gt;60 years), or bifocal tumors were associated with decreased glioblastoma recurrence. However, factors like tumor site, size, necrosis, MGMT promoter methylation, and EGFR alteration showed no significant association with recurrence. Median survival was 12 months, with older age significantly associated with shorter survival. Tumor sizes &gt;4 cm showed shorter survival trends but not statistically significantly. Patients who lived longer experienced more tumor recurrence incidents. Standard or non-standard treatments were associated with longer median survival compared to no treatment. Our findings provide insights into factors influencing glioblastoma recurrence and survival. Age, gender, and tumor characteristics play pivotal roles in recurrence. Understanding these factors could aid in optimizing treatment strategies and improving patient outcomes. However, further multicentric investigations are needed to validate these findings. This study emphasizes the importance of considering biological and radiological factors in clinical decision-making for glioblastoma cases.

Robotic minimally invasive inguinal hernia repair with the Dexter robotic system™: A prospective multicenter clinical investigation

BackgroundRobot-assisted transabdominal preperitoneal inguinal hernia repair (rTAPP) has been established with various robotic platforms. The Dexter robotic system is an open platform consisting of a sterile surgeon’s console, two robotic instrument arms, and one robotic endoscope arm. This study aimed to confirm the perioperative and early postoperative safety and clinical performance of the Dexter system in patients undergoing primary transperitoneal inguinal hernia repair.MethodsThe primary objectives of this multicenter study conducted at three centers in France, Germany, and Switzerland were to document the successful completion of rTAPP procedures and the occurrence of serious adverse events (Clavien–Dindo grades III–V), device-related events up to 30 days post-surgery. The procedures were performed by three surgeons with varying levels of experience in robotic systems.Results50 patients with a median age of 62.5 years (IQR 51.0–72.0) and BMI of 25.1 kg/cm2 (IQR 23.5–28.7), respectively, underwent inguinal hernia repair (33 unilateral, 17 bilateral). All surgeries were successfully completed using three standard laparoscopy trocars. There were no conversions to open surgery, intraoperative complications or device deficiencies. The median skin-to-skin operative time was 50 min (IQR 45–60) for unilateral hernias and 96 min (IQR 84–105) for bilateral hernias. The median console time was 30 min (IQR 26–41) for unilateral and 66 min (IQR 60–77) for bilateral hernias. Twenty-six patients were discharged on the day of surgery, and 22 on postoperative day 1.ConclusionThis study confirmed the use of the Dexter system in rTAPP was feasible and safe in multicenter cohorts, with operative times consistent with the literature on other robotic platforms. Our data demonstrated the accessibility of this new robotic approach, even when adopted by surgeons new to robotics. The Dexter system emerged as a valuable device in the hernia repair toolkit for both experienced robotic surgeons and those new to the field.

Predictors of acute kidney injury in chronic kidney disease patients treated for cardiovascular disease in the cardiac intensive care unit (MORCOR-TURK subgroup analysis).

Acute kidney injury (AKI) is a common complication in chronic kidney disease (CKD) patients in the cardiac intensive care unit (cardiac ICU). In this study, we aimed to identify predictors of AKI in CKD patients treated in the cardiac ICU for cardiovascular diseases. The MORCOR-TURK trial was conducted as a multicenter, prospective, cross-sectional, and noninterventional investigation. A total of 3157 patients treated in the cardiac ICU were enrolled from 50 centers over the course of one month. In this subgroup analysis, 615 patients with CKD treated in the cardiac ICU for cardiovascular disease were included in the study. The primary outcome of this study was the development of AKI. During hospitalization, patients who developed AKI were identified. AKI developed in 288 patients (46%). After multivariable analysis, decompensated heart failure (OR: 3.72, p = 0.005), primary percutaneous coronary intervention (OR: 3.75, p = 0.004), non-primary percutaneous coronary intervention(OR: 2.85, p = 0.033), troponin levels (OR: 1.04, p = 0.031), and need for mechanical ventilation (OR: 3.11, p < 0.001) were identified as independent predictors of AKI development in CKD patients. Our efforts to identify AKI predictors in cardiac ICU patients with CKD have yielded directly applicable results in clinical practice. AKI can be prevented by developing personalized strategies to follow up and treat cardiac ICU patients with CKD who have decompensated heart failure, are undergoing percutaneous coronary intervention (primary and non-primary), have high troponin levels, and need mechanical ventilation.

Development and validation of a risk prediction model for postpartum urinary incontinence in primiparas with singleton pregnancies: a multicenter clinical investigation.

Postpartum urinary incontinence (UI) is a serious condition that significantly affects the quality of life. Several studies have demonstrated that it is associated with pelvic floor dysfunction. This study aimed to develop and validate a UI risk prediction model to identify primiparas with singleton pregnancies at high risk. A multistage stratified random sampling process was used. UI was measured using the International Standard Consultation on Incontinence Questionnaire Form (a modified Bristol questionnaire, ICIQ-FLUTS). Records of 1,340 primiparas with singleton pregnancies were reviewed, and data were collected from January 2014 to December 2014 in multiple centers. A univariate logistic regression analysis was performed, followed by a multivariable logistic regression analysis of the data. Using bootstrap resampling, we constructed a nomogram to assess postpartum UI risk. A total of 1,340 patients were enrolled, including 345 with postpartum UI and 995 with non-postpartum UI. The occurrence of postpartum UI was significantly related to the mode of delivery, family history of UI, coffee or tea consumption, antenatal UI, and frequent cough. The nomogram exhibited good discriminatory ability with a C-index of 0.718 (95% confidence interval: 0.684-0.752) and a bootstrap-corrected C-index of 0.716. Additionally, the calibration curve demonstrated that the predicted outcomes aligned well with the actual observations. Ultimately, the decision curve analysis indicated that the nomogram exhibited favorable clinical applicability. The decision curve analysis suggests that the nomogram could provide clinical value. The clinician will then feel more confident about making clinical recommendations regarding postpartum UI screening for primiparous women with singleton pregnancies.